Steerable sphincterotome and methods for cannulation, papillotomy and sphincterotomy

ABSTRACT

The present invention relates to methodology of and apparatus for accurately positioning devices for performing endoscopic cannulation, papillotomy and sphincterotomy and similar procedures. The sphincterotome with a steerable or adjustable distal segment of the present invention allows the physician to control the position of the distal tip of the device independently of the endoscope and adjust for inconsistencies in the device and the anatomy. According to one embodiment of the present invention, a threaded portion of a cable assembly cooperates with a torque transmission element and a cog to enable the operator to rotate a cutting wire into a desired position relative to the catheter. Alternate embodiments allow the operator to fix the depth of a needle knife while allowing, if desired, accurate rotational positioning of the associated catheter. Threaded stabilizing elements, pivot elements and a steering wire may be used together or individually to accomplish these features. Presently available products that may be modified according to the present invention include, but are not limited to, Boston Scientific Sphincterotomes and Needle Knives.

This is a continuation of both: U.S. Ser. No. 09/761,843 filed Jan. 18,2001, now U.S. Pat. No. 6,579,300; and, also U.S. Ser. No. 10/436,074filed May 13, 2003, now allowed.

BACKGROUND

1. Field of the Invention

This invention generally relates to apparatus that is useful inperforming diagnostic and therapeutic modalities in the biliary tree andmore particularly to apparatus that is adapted for facilitating thediagnosis of gallstones in the bile duct and other portions of thebiliary tree and the removal of such gallstones.

2. Description of Related Art

According to the present state of the art, endoscopic cannulation of thecommon bile duct and papillotomy and/or sphincterotomy of the Papilla ofVater and/or the Sphincter of Oddi is accomplished by advancing asphincterotome (or papillotome or cannulotome) into anendoscope/duodenoscope so that the distal tip of the sphincterotomeexits the endoscope adjacent the sphincter muscles at the Papilla ofVater. The endoscope mechanisms are then manipulated to orient thedistal tip of the sphincterotome to the desired position for propercannulation of the duct. Due to inconsistencies in the sphincterotome,anatomy, and endoscope manipulation, it is difficult to accurately andconsistently position the sphincterotome for proper cannulation.

Historically the migration of gallstones into an individual's commonbile duct was corrected by general surgical procedures. A surgeon wouldincise the bile duct and remove the gallstones and normally remove thegallbladder. In recent years less invasive treatment modalities havereplaced these general surgical procedures and reduced patient trauma,long hospital stays and recovery periods.

For example, U.S. Pat. No. 4,696,668 and U.S. Pat. No. 4,781,677, bothto Wilcox, disclose a treatment modality involving the administration ofa dissolution agent in the bile duct to essentially dissolve anygallstones. More specifically, a catheter contains several lumens forinflating and deflating each of two balloons, venting bile, and infusingand aspirating the dissolution agent. Inflating the balloons occludesthe bile duct at two spaced sites and creates a sealed spaced thatreceives the dissolution agent. As the space is sealed from theremaining biliary tree, the dissolution agent finds access to thegallbladder and any gallstones therein through the cystic duct with theexclusion of bile from the gallbladder fundus. The dissolution agentalso will be confined in high concentration around bile duct gallstones.After the gallstones dissolve the balloons are deflated and the cathetercan be withdrawn. In this particular approach, the catheter is directedinto the biliary tree using a standard duodenoscope that passes throughthe alimentary tract. Although this and analogous approaches have thepotential of minimizing patient trauma, such treatments require extendedplacement of the duodenoscope in the patient, exhibit low efficacy andintroduce a potential for adverse reactions to the dissolution agents.

In an alternative approach, a surgeon directs a surgical extractor intothe biliary tree through at least an incision in the bile duct. Forexample, in U.S. Pat. No. 3,108,593 to Glassman a surgeon incises boththe bile duct and duodenum. Then the surgeon directs an extractorthrough the bile duct incision, biliary tree, sphincter of Oddi andduodenum to exit through the duodenum incision. This extractor includesa series of longitudinally spaced cages for trapping any gallstones inthe bile duct and removing them through either of the incisions.

U.S. Pat. No. 4,627,837 to Gonzalo discloses a catheter device with apair of inflatable balloons at its distal end. This catheter is ledthrough an incision in the bile duct toward the duodenum. After thedistal balloon passes through the sphincter of Oddi, both balloons areexpanded to anchor the catheter in place. This enables the catheter tobe used for irrigating and flushing through other lumens in order tocapture any gallstone in the second balloon for removal through theincised bile duct.

In accordance with still another modality as for the treatment ofstrictures, a surgeon may insert a catheter device through the bile ductor duodenum for the purpose of dilating or enlarging the sphincter ofOddi. For example, U.S. Pat. No. 4,705,041 to Kim discloses a dilatorthat is directed through an incision in the bile duct and the sphincterof Oddi. An expandable tip dilates the sphincter of Oddi. U.S. Pat. No.5,035,696 to Rydell discloses an electrosurgical instrument that isdirected through the duodenum and to the sphincter of Oddi forperforming a sphincterotomy. This apparatus contains a cutting wire thatis heated to cut the sphincter muscle. U.S. Pat. No. 5,024,617 toKarpiel, discloses a similar device that can be directed through aduodenoscope. U.S. Pat. No. 5,152,772 to Sewell, Jr. discloses a devicefor performing a sphincterotomy that is directed through an incision inthe bile duct and includes a knife for cutting the sphincter muscle.

The use of the duodenoscope and sphincterotomy devices, such as shown inthe Rydell and Karpiel patents, enables an internist to diagnose andtreat problems in the biliary tree with minimal patient invasion. Forexample, modalities as described in these patents eliminates the surgeryneeded for incising the bile duct. Consequently, these modalities can beperformed as outpatient or day surgical procedures. These proceduresgreatly reduce patient trauma, the length of a hospital stay andrecovery times. For example, if an internist determines that gallstonesare present in the biliary tree, particularly the common bile duct, theinternist can insert a duodenoscope into the duodenum to view thesphincter of Oddi. Then a first catheter can be advanced through theworking channel of the duodenoscope with or without a guidewire anddirected through the sphincter of Oddi into the biliary tree. Contrastagent injected through the catheter enables fluoroscopy or other imagingprocedures to confirm the presence of gallstones within the biliarytree. Next the internist exchanges the first catheter for a secondcatheter for performing a sphincterotomy such as the types disclosed inthe above-identified Rydell and Karpiel patents. The second catheter isthen exchanged for a third catheter such as shown in the Glassman patentor some other equivalent retrieval catheter for drawings gallstonesthrough the enlarged sphincter of Oddi. Thereafter the retrievalcatheter is manipulated to release the gallstone into the duodenum. Thecatheter, any guidewire and the duodenoscope can then be removed tocomplete the procedure.

This procedure is significantly less traumatic to the patient than otherprior art procedures because the only incision occurs during thesphincterotomy. However, this procedure, as described above, requiresthree separate catheters and two catheter exchanges. These exchanges arerequired because the first, second and third catheters function solelyto inject contrast agent to perform the sphincterotomy and to dislodgegallstones, respectively. The time required for performing each catheterexchange can increase patient trauma and increase the duration of theprocedure and reduce efficiency. Moreover, each such procedure requiresthe use of two or three separate catheter devices.

Multi-lumen catheters are available which typically reduce the number ofcatheters and catheter exchanges used during a procedure and therebyreduce both the time required and the patient's trauma while increaseefficiency. The use of multi-lumen devices also eliminates the need forthe repositioning of subsequent catheters because the original catheterwas withdrawn. While the multi-lumen device may have to be repositioned,the repositioning is considerable less then when a single lumen catheteris used. While precision positioning of the multi-lumen device isessential for safe and effective results, accurate positioning of themulti-lumen device is difficult to achieve. State of the art multi-lumendevices are typically positioned by torque transmission from the handleto the distal tip approximately 6 feet away. Additionally, when anincision is made, proper knife depth is difficult to maintain because ofthe connection between the knife lumen and the knife shaft. Whenpressure is applied to the knife lumen an undesirable movement of theneedle knife tip may occur because of this imprecise connection.

A need exists for an apparatus and a methodology of accurate placementof catheters, multi-lumen devices and needle knives. A further needexists for an apparatus for and a methodology of an accurate depthcontrol for needle knives and other cutting instruments.

SUMMARY

Therefore, this invention provides an apparatus for, and a methodologyof, accurate placement of the catheter, papillotome, sphincterotome,and/or needle knife. This invention further provides an apparatus for,and a methodology of, accurate control of the depth of the needle knifeand the resulting incision and an apparatus which can allow accuratecontrol of the depth of the needle knife while allowing the user toaccurately place the needle knife within the patient.

The invention discloses an endoscopic catheter which has a distallylocated tissue cutting device in a first lumen, and includes a secondlumen which has 1) a reciprocating cable inside and 2) includes a fixedmember which is used to impart rotary motion to the cable inside of itwhere the reciprocation of the cable causes a rotation of at least thedistal portion of the catheter to orient the cutting device. The cablemay have spiral threads on its outer circumference and the fixed membermay have spiral threads on its inner circumference which mate with thethreads on the cable. The cutting device may be a sphincterotome, apapillotome or a needle knife with a curved distal portion and thecutting device may operate in response to energy from an rf heatingsource.

In another embodiment a sliding member may be included which is attachedto the distal end of the cable and is located distal from the fixedmember. The cross section of the lumen containing the sliding member aswell as the cross section of the sliding member may be non-round or evensquare.

In another embodiment of the invention, an endoscopic catheter has acable actuated needle knife within a lumen where the needle knife isdeployable from a distal end of the catheter. In this embodiment theinvention substantially prevents movement of the needle knife afterdeployment and includes a distally positioned fixed stabilizing elementin the lumen which internally engages the needle knife cable to preventsuch motion. The cable attached to the needle knife may have spiralthreads on its outer circumference and the fixed stabilizing element mayhave spiral threads on its inner circumference which mate with thethreads on the cable. The needle knife may have a curved distal portionand the cutting device may operate in response to energy from an rfheating source. A pivot element may be included, preferably proximal tothe stabilizing element, to prevent torsion build up within the cable.

In another embodiment, the invention includes an endoscopic catheterhaving a cable actuated needle knife within a first lumen deployablefrom a distal end of the catheter and the cutting device may besubstantially prevented from movement after deployment. In thisembodiment a second lumen containing a reciprocating cable and a fixedmember imparts rotary motion to the cable when reciprocated.Reciprocation of the cable causes rotation of at least a distal portionof the catheter to orient the cutting device and a distally positionedfixed stabilizing element in the first lumen internally engages theneedle knife cable to substantially prevent movement. The cable may havespiral threads on its outer circumference and the fixed member may havespiral threads on its inner circumference which mate with the threads onthe cable. The cutting device may be a needle knife with a curved distalportion and the cutting device may operate in response to energy from anrf heating source. A pivot element and/or a sliding member may beincluded.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of this inventionwill be more fully apparent from a reading of the following detaileddescription in conjunction with the accompanying drawings in which likereference numerals refer to like parts, and in which:

FIG. 1 is a plan view of one embodiment of apparatus constructed inaccordance with this invention;

FIG. 2 is a cross-section taken along lines 2-2 in FIG. 1;

FIG. 3 is a cross-section taken along lines 3-3 in FIG. 2;

FIG. 4 depicts the apparatus of FIG. 1 positioned through a duodenoscopefor injecting contrast agent into the biliary tree;

FIG. 5 is an enlarged view that depicts the orientation of the apparatusin FIG. 1 for performing a sphincterotomy;

FIG. 6 depicts the apparatus of FIG. 1 positioned through a duodenoscopefor dislodging material within the common bile duct;

FIG. 7 is a cross-section of an alternative embodiment of the apparatusas viewed generally along lines 7-7 in FIG. 2;

FIG. 8 is a cross-section of still another embodiment of the apparatustaken along lines 7-7 in FIG. 2;

FIG. 9 is a partial cross-section of the invention highlighting thepositioning device;

FIG. 10 is a cutaway view of an alternative embodiment of the presentinvention used to support the extension of the needle knife;

FIGS. 11A and 11B are enlarged views of the a pivot element and astabilizing element from FIG. 10; and

FIG. 12 is a plan view of an alternate embodiment of the presentinvention which combines a positioning device and a support for theneedle knife.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

FIG. 1 depicts catheter apparatus 100 that has the capability ofinjecting a contrast agent into the biliary tree, accurately positioninga cutting wire, of performing a sphincterotomy and of dislodging agallstone into the duodenum. Apparatus 100 includes a catheter 101which, for purposes of definition, includes proximal portion 102extending from proximal end 103 and distal end 104 with distal portion105 extending a short distance from distal end 104. In a typicalapplication, the catheter will have a working length of 200 cm anddistal portion 105 will have a length of 6 cm to 9 cm. Normally distalportion 105 will have a diameter that is smaller than the diameter ofproximal portion 102 to increase the flexibility of distal portion 105.The reduction in diameter also makes distal end 104 less traumatic andallows distal portion 105 to reach smaller passages while allowing thelarger proximal portion 102 to provide necessary hoop strength andrigidity, particularly where proximal portion 102 is coextensive withthe working channel of a duodenoscope. For example, the proximal anddistal portions might have diameters corresponding to 7 Fr and 5.5 Frcatheter sizes (i.e., 0.09″ and 0.07″ respectively).

As shown particularly in FIG. 2, catheter 101 has three lumens. Firstlumen 201 has a diameter that is greater than either second lumen 202 orthird lumen 203. In one particular embodiment first lumen 201 is squareshaped with each side approximately 0.040″ in proximal portion 102 thatreduces to about 0.037″ in distal portion 105 to receive a standard0.035″ guidewire. In addition first lumen 201 may be, and as shown inFIG. 2, is offset from the center of the catheter 101.

The cross section of both second lumen 202 and third lumen 203 are eachsmaller than the cross section of first lumen 201 and are radiallyoffset from the centerline of catheter 101, from each other and fromfirst lumen 201. In one particular embodiment the cross section of thirdlumen 203 has a diameter of 0.028″ in proximal portion 102 that reducesto about 0.020″ in distal portion 105 and second lumen 202 has aninternal diameter of 0.028″ in proximal portion 102 that reduces toabout 0.020″ in distal portion 105. As described later, this third lumen203 carries a cutting wire for performing a sphincterotomy and forallowing the infusion of a contrast agent at reasonable rates. Thecutting wire can also be positioned, as described later, as desired.While the description contained herein describes the first lumen 201having a square cross section shape, it would be apparent to one ofordinary skill in the art that the invention may be practiced in any ofthe lumens by changing the cross section of the lumen to a shape otherthan a circle. The angular spacing between second lumen 202 and thirdlumen 203 is about 45 degrees and the angular spacing between firstlumen 201 and each of lumens 202 and 203 each is about 157.5 degrees. Inthis configuration and with these dimensions proximal portion 102readily passes through the working channel of any duodenoscope. Theseangular relationships have been used in the past to position the device.While the invention may be used with these angular relationships, theinvention itself allows the device to be positioned which reduces thenecessity of strict adherence to the previously used angularrelationships.

Referring again to FIGS. 1 and 2, each of lumens 201, 202 and 203includes an entry port in proximal portion 102 and an exit port indistal portion 105. Generally, and as described in more detail later,first lumen 201 has an exit port through distal end 104 while the exitports for lumens 202 and 203 can be sited at different locations indistal portion 105 depending upon a particular application.

In FIG. 1, the entry ports in proximal portion 102 adjacent proximal end103 include an entry port 106 that provides access to first lumen 201and includes an optional Leur lock fitting 107. Proximally positionedentry port 108 provides access to second lumen 202 and includes optionalLeur lock fitting 109. Proximal entry port 110 for third lumen 203 islocated coextensively with a portion of handle 111 attached to proximalend 103. One of ordinary skill in the art would understand that thisspecific configuration is given as an example and not meant to limit theinvention. Various other configurations would be apparent to one ofordinary skill in the art to practice the invention described herein.

Referring to the distal portion 105, catheter 101 in this particularembodiment carries expansible balloon 112 proximally of the excursion ofcutting wire 113 externally of catheter 101. As described in U.S. patentapplication Ser. No. 09/154,834 in the name of Rowland, et al., andowned by the owner of the present application and already incorporatedherein by reference in its entirety, second lumen 202 emerges at adistal exit port through the side of catheter 101 with the interior ofexpansible balloon 112. An extension of second lumen 202 beyond thedistal port is sealed by known methods of manufacture. Consequently,fluid forced through entrance port 108, as by a syringe (not shown)attached to Leur lock fitting 109, expands balloon 112 into an occludingorientation with an inflated diameter in the range up to 20 mm.

First lumen 201 extends through catheter 101 and terminates with an exitport in distal end 104. Thus first lumen 201 is adapted for receiving aguidewire through the entry port 106 that will extend through catheter101 and exit distal end 104 and allow the catheter to slide over thatguidewire.

Referring to FIG. 3, distal end 301 of cutting wire 113 attaches to aclamp 302 formed at the distal end of third lumen 203. Spaced skivedports 303 and 304 allow active portion 305 of the cutting wire 113 toemerge from catheter 101 through skived aperture 303, parallel thecatheter 101 exteriorly thereof and return into third lumen 203 throughport 304 and reinforcing sleeve 306. Cutting wire 113 then extendsthrough third lumen 203 to handle 111 shown in FIG. 1 where it emergesas proximal end portion 114.

Handle 111, as shown in FIG. 1, includes central member 115 terminatingwith thumb ring 116. The central member 115 extends through and slideswith respect to body section 117 having opposed finger rings 118. Thecentral member 115 also attaches to catheter 101, and is therefore anextension of catheter 101. Member 117 additionally includes internalconnector 119 for clamping proximal end 114 of cutting wire 113. Thus,when body 117 is at its distal position as shown in FIG. 1, distalportion 105 of catheter 101 is in essentially straight line as shown inFIG. 1 with active portion 305 of cutting wire 113 being closelyadjacent catheter 101. Retracting body portion 117, causes cutting wire113 to bend distal end 104 upwardly as shown in FIG. 3 to a positionthat is essentially at right angles to the main axis of the catheter, aswill be shown later.

Connector block 119 and cutting wire 113 are generally conductivemembers that attach through RF connector 120 to RF heating source 121.The use of such RF heating sources 121 for energizing cutting wire 113thereby to cut the sphincter muscle is well known in the art andrepresents one possible sphincterotomy procedure that can be adapted forthe apparatus of this invention and is not described further.

With this description of the apparatus structure, it will now bepossible to understand its use in a particular application. FIG. 4discloses, in a partially broken and schematic view, the positioning ofduodenoscope 401 in duodenum 402 adjacent sphincter of Oddi 403.Catheter 101 such as constructed in FIG. 1 passes through sphincter ofOddi 403 into the common bile duct 404, bypassing pancreatic duct 405.Distal end 104 does not extend to gallbladder 406.

Fluoroscopy allows the appropriate positioning by utilizing a series ofradio-opaque markers 406 at distal portion 105 that may include clamp302 and reinforcing sleeve 306 in FIG. 3. Catheter 101 can be positionedwith or without the presence of guidewire 408 in first lumen 201 shownin FIGS. 2, and 3. For purposes of injecting the contrast agent, anyguidewire 408 can be withdrawn to allow the contrast agent to beinjected through first lumen 201 for purposes of fluoroscopicexamination to confirm the presence of one or more gallstones 409. It isalso possible during the operation to expand balloon 112 to occludecommon bile duct 404 and block any migration of contrast agent intoduodenum 402 or pancreatic duct 405.

FIG. 5 is an enlarged view showing duodenum 402, sphincter of Oddi 403,portions of pancreatic duct 405 and common bile duct 404. In FIG. 5catheter 101 has been positioned relative to the duodenoscope 401through the opening of sphincter of Oddi 403. The handle 111 in FIG. 1has been drawn proximally to deflect distal portion 105 into essentiallya right angle configuration such that cutting wire 113 abuts a portionof sphincter of Oddi 403. The application of RF heating to cutting wire113 then will cut sphincter of Oddi 403 and enlarge the openingtherethrough. As will be apparent, the sphincterotomy is performed withdirect visualization of the sphincter of Oddi through the duodenoscope.

Moreover, as has been observed by others, catheters having guidewire andcutting wire lumens tend to assume a particular angular orientation whendistal portion 105 emerges from the duodenoscope. This orientation isessentially independent of the angular position of the catheter when itis inserted into the duodenoscope. The offset nature of lumen 203 asshown in FIG. 2, improves the location of cutting wire 113 as distalportion 105 passes through sphincter of Oddi 403. Specifically theangularly offset brings cutting wire 113 into better alignment withcommon bile duct 404 and displaces the cutting wire from pancreatic duct405.

FIG. 6 depicts the catheter after the sphincterotomy and after catheter101 is advanced over guidewire 408, if used. FIG. 6 also disclosescatheter 101 after balloon 112 has been moved beyond gallstone 409 inbile duct 404. Balloon 112 is expanded so that upon withdrawal ofcatheter 101 balloon 112 will dislodge gallstones 409 and sweep themthrough sphincter of Oddi 403 into duodenum 402.

As will now be apparent from the description of the particular catheterapparatus 100 shown in FIG. 1 and its use as discussed with respect toFIGS. 4, 5, and 6, the single catheter apparatus is capable of providingdiagnostic contrast agent injection, of performing a sphincterotomy andof dislodging gallstones in the common bile duct or other portions ofthe biliary tree without having to exchange a catheter. Moreover,positioning and sizing of the lumens enables these functions to beperformed with a catheter apparatus that is readily adapted for use inthe working channels of standard duodenoscopes. Consequently thegallstones can be removed from the biliary tree without bile ductincisions and accompanying surgical procedures, as duodenoscope can beintroduced through the alimentary tract. Consequently the entireprocedure is adapted for being performed more rapidly than prior artprocedures and with fewer components. The net effect is to reducepatient trauma and the overall time and cost of conducting theprocedure.

In FIG. 1 balloon 112 is located proximally of cutting wire 113. FIG. 7discloses an alternative embodiment in which balloon 701 is locateddistally of cutting wire 113. More specifically, the distal end of lumen202A, corresponding to second lumen 202 in FIG. 3 is sealed. Side facingexit port 702 skived or otherwise formed in catheter 101 opens intochamber 703 formed by balloon 701. First sealing portion 704 and asealing portion 705 of balloon 701 connect proximally and distally ofaperture 702 respectively and seal chamber 703.

Introduction of a balloon inflation fluid through lumen 202A expandsballoon 701 into an occluding orientation corresponding to theorientation of balloon 701. Retraction of catheter 101 with distalballoon 701 inflated enables withdrawal of a gallstone from the bileduct. This particular embodiment is particularly adapted when it isdetermined that a gallstone is located high in the biliary tree tominimize the incursion of distal portion 105 through the biliary treebeyond the gallstone or in any application in which the internistdesires to minimize the length of distal portion 105 that extends beyondthe occluding balloon.

FIG. 8 discloses another embodiment for enlarging the sphincter of Oddiand performing another procedure, such as injecting a contrast agentinto the biliary tree, as might be used in the diagnosis and treatmentof a stricture in the biliary tree. In this particular embodiment exitport 801 from second lumen 202B is located in distal end 104 of distalportion 105. First lumen 201 then can be used for a guidewire and lumen202B, for injecting the contrast agent directly into the biliary treewhile the guidewire remains in place. The apparatus would then bepositioned to perform a sphincterotomy without having to exchange acatheter should the procedure be warranted.

As still another alternative, the internist could utilize a conventionalcatheter for purposes of injecting the contrast agent to determine theneed for gallstone removal. If treatment were indicated, the internistcould then utilize apparatus as shown in FIG. 1 with a single exchangeover the guidewire that would pass through lumen 201 as previouslydescribed.

As can be seen from the above description one of the steps in thetreatment of obstructive disease is normally the practice of tissueincision which is achieved by advancing a cutting wire endoscopically tothe target site. As explained above, once the catheter tip is inposition, the catheter tip is bowed (FIG. 5) to expose cutting wire 113to tissue. Diathermic current is passed through cutting wire 113 from RFHeating Source 121 (FIG. 1) which allows the endoscopist to incise andcauterize the tissue at the target site. Safe and effective results areonly obtained through precision positioning of cutting wire 113.

FIG. 9 depicts a section of a positioning device 900 residing withinlumen 201 of a multi-lumen catheter 101. As shown in FIG. 2 lumen 201has an internal shape, in this case a square, which allows thepositioning device 900 to transfer torque to distal end 104. Theinternal shape of lumen 201 in FIG. 2 is depicted to be a square, butone of ordinary skill in the art would understand that any internalshape which allows the torque transfer may be used and is within thedisclosed invention. Referring back to FIG. 9, positioning device 900consists of cable assembly 901, which is substantially encircled bytorque transmission element 902 and cog 903. Proximate end 904 ofpositioning device is attached to handle 111 (not shown) while distalend 905 of positioning device 900 is located in the distal portion 105(not shown). While FIG. 9 illustrates a torque transmission element 902which completely encircles cable assembly 901, it would be apparent toone of ordinary skill in the art that torque transmission element 902need not entirely encircle cable assembly 901 and any configurationbetween torque transmission element 902 and cable assembly 901 whichallows the translation of reciprocal movement to rotational motion iswithin the scope of the invention. The cog 903 can also be referred toas a sliding member.

Cable assembly 901 is connected at its proximal end (not shown) to thedistal end of handle 111, traverses through lumen 203 and torquetransmission element 902 with the distal end of cable assembly 901 fixedto cog 903. Reciprocal motion of the handle 111 attached to the cableassembly 901 introduces reciprocal motion in the proximal portion of thecable assembly 901 between the handle 111 and torque transmissionelement 902. The outer circumference 906 of the cable assembly 901includes a helical or advancing spiral thread.

The torque transmission element 902 is located and fixed within lumen201 a short distance from distal end 104 (FIG. 1) and proximal to cog903. The internal portion of torque transmission element 902, or theportion which comes into contact with the cable assembly 901, contains ahelical or advancing spiral thread which interacts and mates with thehelical or advancing spiral thread of cable assembly 901. The externalportion of torque transmission element 902, or the portion which comesinto contact with lumen 201, is shaped to interact with and mate withthe interior surface of lumen 201 and is fixed to inner lumen 201. Thepurpose of torque transmission element 902 is to change the reciprocalcable movement received from the reciprocal movement of the attachedhandle 111 to rotational cable movement in direction 907. The torquetransmission element 902 may be molded as part of or attached to lumen201.

The cog 903 is located between torque transmission element 902 anddistal end 104 and at a distance from each so as to aid in creatingeffective rotation of the catheter distal end 104. This rotation, in thedirection of 907, is the result of the torque transmission element 902translation of the reciprocal movement received from handle 111 intorotational cable movement. As torque transmission element 902 receivesreciprocal movement from cable assembly 901, torque transmission element902 cannot moved because it is fixed to lumen 201 and the internalhelical or advancing spiral inside of torque transmission element 902imparts a rotational affect on cable assembly 901 in a similar manner tothe spin a bullet receives from the rifling inside of a rifle's barrel.Cog 903 is not fixed to lumen 201 and is capable of reciprocal movementwithin lumen 201 as the cable assembly 901 advances and retracts. Thepurpose of cog 903 is to transfer the torque received from cableattached to torque transmission element 902 to the distal segment of thecatheter and this is achieved when cog 903 is fixed to cable assembly901. While the invention is shown with cog 903, one of ordinary skill inthe art would understand that the cog 903 is not absolutely necessary tothe invention, but instead aids in the transmission of the torquecreated by torque transmission element 902. Cog 903, while included inthe preferred embodiment, may be eliminated and the distal tip 104 wouldstill be capable of being positioned. The resistance between the torquetransmission element 902 and the cable assembly 901 may be varied toadjust the proportion of the reciprocal movement which is translatedinto rotational motion. Cog 903 may also be shaped to increase theefficiency of the transfer of rotational movement from the distal end ofthe cable to the distal segment of the catheter. For example, where thecross-section of lumen 201 is in the shape of a square the cross sectionof cog 903 would also be a square.

In operation distal end 104 of the cutting device is advanced throughthe lumen 203 of the endoscope to the target area Cutting wire 113 isretracted to bow the tip exposing the cutting wire (FIG. 5). The distalend of device 900 is advanced through lumen 201 until torquetransmission element 902 is in, or near the distal portion 105. Thehandle 111, which is connected to cable 901, is reciprocated, causingthe proximal end 904 of cable assembly 901 to be reciprocated. When theproximal end of cable assembly 901 is reciprocated, torque transmissionelement 902 translates this movement into rotation which is transferredfrom cog 903 to the catheter distal end 104. As catheter distal end 104is rotated so is cutting wire 113 which resides in lumen 203. After theincision is made in the target area, cutting wire 113 is advancedrelieving the bow. The catheter assembly can then be removed from thebody. Overall, the effect of the positioning system 900 is to translatethe reciprocal movement in the handle 11 into rotational movement at thedistal end 104 of the catheter.

FIG. 10 depicts a multi-lumen catheter 1000 which includes an alternateembodiment of the present invention for the precise positioning of aneedle knife. Within catheter 101 of multi-lumen catheter 1000 is lumen1001 which is used for needle knife 1002. Within lumen 1001 residesneedle knife wire 1003. Needle knife wire 1003 is attached at theproximal end to a sliding mechanism of handle 1004 and on the distal endto needle knife 1002. Needle knife 1002 is capable of extending beyonddistal end 104 of catheter 101. Circumference 1005 of needle knife wire1003 includes helical or advancing spiral 1006. FIG. 10 shows helical oradvancing spiral 1006 along the entire length of needle knife wire 1003,but helical or advancing spiral 1006 portion of needle knife wire 1003need not be included along the entire length and may be limited toinclusion over a short distance of needle knife wire 1003 close to thedistal end 104. Helical or advancing spiral 1006 is required where pivotelement 1007 and stabilizing element 1008 attach and along needle knifewire 1003 where pivot element 1007 and stabilizing element 1008 maytravel. In one embodiment the helical or advancing spiral 1006 may belocated between 6 and 10 cm from the distal end.

Pivot element 1007 and stabilizing element 1008 are attached to needleknife wire 1003. Pivot element 1007 is located proximal to stabilizingelement 1008 and is used to prevent torsion build up. While thepreferred embodiment includes pivot element 1007, the invention can bepracticed without the inclusion of pivot element 1007. Stabilizingelement 1008 is located a short distance from distal end 104 and may bemolded as part of the lumen or attached to the lumen. In one embodimentthe stabilizing element 1008 was located 6 to 10 cm from the distal tip.The purpose of the stabilizing element is to prevent needle knife 1002from being pushed back into lumen 1001 when pressure is applied to theneedle knife 1002, for example when an incision is made. The stabilizingelement 1008 is part of or fixed to the lumen wall and uses thisattachment to prevent the needle knife 1002 from being pushed back intothe lumen. Stabilizing element 1008 may have a helical or advancingspiral 1109 (FIG. 11B) along its inner circumference which mates withthe helical or advancing spiral 1006 of needle knife wire 1003.

When the sliding mechanism of handle 1004 which is attached to needleknife wire 1003 reciprocates, needle knife wire 1003 also reciprocates.As needle knife wire 1003 reciprocates, threaded needle knife wire 1003rotates through stabilizing element 1008 and needle knife 1002 advancesout of or retracts into lumen 1001. The sliding mechanism of handle 1004can be locked when needle knife 1002 is deployed to its desired length.As pressure is applied to needle knife 1002 during incision any forwardor backward movement of needle knife 1002 is negated by stabilizingelement 1008 which acts, to resist movement of the needle knife backinto the lumen 1001. This resistance is created by the interaction ofthe matched helical windings of the stabilizing element 1008 and theneedle knife wire 1003. Stabilizing element 1008 allows needle knife1002 to be locked regardless of the overall catheter length.

In operation distal end 104 of device 100 is advanced through theendoscope to the target area Needle knife wire 1003 is advanced via thesliding mechanism of handle 1004 to expose needle knife 1002 to thedesired length. The sliding mechanism of handle 1004 is then locked intoposition. As pressure is applied to needle knife 1002 during theincision, stabilizing element 1008 ensures the integrity of the depth ofcut of needle knife 1002. Once the incision is made in the target area,needle knife 1002 is retracted and the catheter assembly is removed fromthe body.

FIGS. 11A and 11B show a blown up diagram of the pivot element 1007 andthe stabilization elements 1008 respectively. The pivot element shown inFIG. 11A, consists of three parts, a proximal element 1101, a distalelement 1102 and an enclosure element 1103. When the needle knife wire1003 is pushed towards the distal end 104, proximate element 1101 makescontact with distal element 1102 and ensures the entire needle knifewire progresses within the lumen toward the distal end 104. When theneedle knife wire 1003 is retracted, proximal element 1101 contacts theproximal portion 1104 of the enclosure element 1103 and the distalportion 1105 of the enclosure element 1103 contacts the distal element1102 and ensures the entire needle knife wire is retracted. Within thepivot element 1007 is a space 1106 between the proximal element 1101 andthe distal element 1102 and the sides of the enclosure element 1103.There is also a space 1107 between the needle knife wire 1003 and theentrance 1107 and exit 1108 of the enclosure element 1103. Thestabilizing element 1008 is shown in FIG. 11B which highlights themating 1104 between the helical windings on the needle knife wire 1003and the stabilizing element 1008.

FIG. 12 is a perspective view of a device which incorporates both astable needle knife to maintain the blade depth and which allows theuser to position the blade in a desired direction. Within catheter 101of multi-lumen catheter 1200 is lumen 1001 which is used for needleknife 1002. Within lumen 1001 resides needle knife wire 1003. Needleknife wire 1003 is attached at the proximal end to a sliding mechanismof handle 1004 and on the distal end to needle knife 1002. Needle knife1002 is capable of extending beyond distal end 104 of catheter 101. Thecircumference 1005 of needle knife wire 1003 includes helical oradvancing spiral 1006. In one embodiment the helical or advancing spiral1006, 6 cm of the needle knife wire includes the helical or advancingspiral feature which is located at a distance of 12 cm from the distaltip. Needle knife (stabilizing) threaded element 1008 is also includedin the device 1200 to prevent the blade 1002 from being pushed back intothe lumen when pressure is applied to the needle knife blade 1002. Themechanism of FIG. 12 which prevents the blade of the needle knife 1002from being pushed back into the lumen has been described with respect toFIG. 10. The needle knife (stabilizing) threaded element may be moldedas part of or attached to the lumen. A pivot element 1007 (FIG. 10) maybe attached to the needle knife wire 1003 if desired.

FIG. 12 also includes a mechanism for steering the position of thecutting wire 113. Steering wire 1201 is connected at its proximal end tothe distal end of handle 1202, traverses through lumen 1203 and steeringwire threaded element 1204. The internal surface of steering wirethreaded element 1204 matches and mates with the external circumferenceof steering wire 1201. As the steering wire 1201 is reciprocated via asliding mechanism on handle 1202, the threaded steering wire 1201rotates through the steering wire threaded element 1204. This rotationcauses the distal section of the catheter to rotate. The slidingmechanism can be locked when the desired position is achieved. In oneembodiment the distal end of the steering wire 1201 was threaded for 10cm at a distance of 8 cm from the distal tip. The major advantage ofdevice 1200 is the ability to rotate the distal tip either clockwise orcounterclockwise as the sliding mechanism is reciprocated and to ensurethe blade of the needle knife does not retract into the lumen when used.The steering wire threaded element may be molded as part of or attachedto the lumen. A cog 903 (FIG. 9) may also be included for a moreeffective transfer of rotational position to the distal end 104.

FIG. 12 also shows a bowing wire 1205 included in device 1200. Theinclusion of the bowing wire 1205 allows the distal tip of the catheterto be turned up to 90 degrees from the longitudinal axis of the catheterbody 101.

In operation the distal tip of the device is advanced through lumen 1001of the endoscope to the target area. Once the distal tip reaches thetarget area, the tip of the catheter is bowed to the desired angle. Thesteering device is then advanced through lumen 1203 until the steeringelement is in, or near, the distal portion 105. The tip of the catheteris than rotated to the desired position and locked when the desiredposition is obtained. The needle knife is than advanced to expose theneedle knife to the desired length. Once the exposed length is attained,the handle is locked to ensure the needle knife blade is not pushed backinto the lumen when pressure is applied to it. The incision is then madein the target area and the needle knife is retracted, the bow isreleased and the catheter assembly is removed from the body.

Therefore, it will now be apparent that apparatus constructed inaccordance with this invention attains the several objects and theadvantages of this invention. More particularly, catheter apparatusconstructed in accordance with this invention allows the injection of acontrast agent, the performance of a sphincterotomy and dislodginggallstones from the common bile duct through the enlarged sphincter ofOddi into the duodenum all without requiring any catheter exchanges.Moreover, this apparatus allows such a procedure to occur through aduodenoscope to minimize patient trauma. The use of a single catheterwith an elimination of catheter exchanges further reduces the time andcosts associated with the use of multiple, single-function catheterdevices.

As will be apparent from the foregoing description, many alterations canbe made to the specifically disclosed embodiments. Different balloonstructures can be used and located at alternative positions. Differentcutting wire embodiments and orientations can be used. Thus, althoughthis invention has been disclosed in terms of certain embodiments, itwill be apparent that many modifications can be made to the disclosedapparatus without departing from the invention. In particular, it isconsidered that all of the foregoing embodiments may be used inconjunction with a handle fixed to the cutting wire but rotatablerelative to the catheter. Therefore, it is the intent of the appendedclaims to cover all such variations and modifications as come within thetrue spirit and scope of this invention.

1. A catheter torque transmission element comprising: a catheter havinga lumen disposed therein; a cable reciprocatingly disposed in saidlumen; and a torque transmission element disposed in said lumen; saidcable reciprocatingly disposed through a hole in said torquetransmission element; said cable having an exterior shaped surfaceportion that is in moveable mating contact with an interior shapedsurface portion of said torque transmission element hole so said cablecan be linearly moved through said torque transmission element hole andthereby produce rotation between said cable and said torque transmissionelement; wherein an exterior shaped surface of said torque transmissionelement is in mating contact with an interior shaped surface of saidlumen so rotational movement of said torque transmission element impartsa rotation force to said catheter.
 2. A catheter torque transmissionelement comprising: a catheter having a lumen disposed therein; a cablereciprocatingly disposed in said lumen; and a torque transmissionelement disposed in said lumen; said cable reciprocatingly disposedthrough a hole in said torque transmission element; said cable having anexterior shaped surface portion that is in moveable mating contact withan interior shaped surface portion of said torque transmission elementhole so said cable can be linearly moved through said torquetransmission element hole and thereby produce rotation between saidcable and said torque transmission element; wherein said pivot elementfurther comprises: an enclosure element, said enclosure element havingan open space formed between a proximal portion and a distal portion;said proximal portion having an entrance opening, and said distalportion having an exit opening; a first portion of said cable disposedthrough said entrance opening, and said first cable portion having anattached proximal element disposed in said open space; and a secondportion of said cable disposed through said exit opening, and saidsecond cable portion having an attached distal element disposed in saidopen space, wherein said first cable portion is not attached to saidsecond cable portion.
 3. A method for providing rotational orientationat a distal end portion of a catheter that has a cable disposed in afirst lumen which comprises: linearly moving said cable in said firstlumen, said cable having an exterior shaped surface portion that ismated with an interior shaped surface portion of a hole passing througha torque transmission element that is disposed in said first lumen; androtating said catheter around said cable by having said torquetransmission element transfer rotation force to said catheter as saidcable is linearly moved through said torque transmission element.
 4. Themethod according to claim 3 wherein said cable exterior shaped surfaceportion is a helical exterior shaped surface portion.
 5. The methodaccording to claim 3 wherein said interior shaped surface portion of thehole through said torque transmission element is a helical interiorshaped surface portion.
 6. The method according to claim 3 wherein atissue cutting device is disposed at a distal end of said cable.
 7. Themethod according to claim 3 wherein said catheter includes a secondlumen, and a tissue cutting device is disposed at a distal end of saidsecond lumen.
 8. The method according to claim 7 wherein said cuttingdevice is a cutting wire.
 9. The method according to claim 7 whereinsaid cutting device is a needle knife.
 10. The method according to claim3 wherein said torque transmission element is fixed to an interiorsurface of said lumen.
 11. The method according to claim 3 wherein anexterior shaped surface of said torque transmission element is in matingcontact with an interior shaped surface of said first lumen so saidtorque transmission element imparts the rotation force to said catheter.12. The method according to claim 3 further comprising relieving torqueforces on said cable by having a pivot element disposed in said firstlumen with a first portion of said cable disposed through an entranceopening into said pivot element and a second portion of said cabledisposed through an exit opening into said pivot element, wherein saidfirst cable portion is not attached to said second cable portion.